FDA Orders 23andMe Off The Market; Apparently Concerned That People Are Too Stupid To Understand Their Own DNA

from the regulatory-overreach? dept

Soon after 23andme launched, there had been regulatory questions about whether it can market its simple DNA test without first getting regulatory approval. There hadn't been much news on that for a few years, so I had been under the assumption that the company had worked through all the regulatory hurdles. However, according to the FDA, the company has actually failed to meet the regulatory hurdles to make the product legal, and they're demanding that the company stop offering its product immediately, and fix problems within 15 working days, or face "regulatory action."

The FDA seems mainly worried that 23andMe's offering may overstate what it can do, and fail to inform people properly of the possibilities of false positives, which could create significant problems:

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.

The FDA further notes that it's been talking to the company for quite some time about this, including: "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" during which it claims to have given the company very specific information and suggestions for how to meet the necessary regulatory hurdles. I certainly recognize the value of the FDA making sure that companies aren't out there promoting quack medicine, which could create very real harms. But there is also something in all of this that suggests a compliance-by-the-numbers approach of trying to fit a square peg into a round hole by the FDA in trying to classify 23andMe as something that it's not. Most people I've known who use 23andMe don't use it as the final word on something, but rather as a simple and cheap way of figuring out where they might want to investigate for a more thorough analysis.

It will be interesting to see how the company responds to the FDA, as this has all the hallmarks of a company doing something unique, new and valuable, where the regulatory systems are simply unable to process. It's entirely possible that there is, in fact, problems with how 23andMe markets its products, but we'll reserve judgment until more details are available. From a basic informational standpoint, however, we have trouble believing that providing individuals with more information about their own genes should be heavily regulated. A more informed populace is a good thing and should be supported. The idea that people are too stupid to understand what information 23andMe provides seems insulting to the public, and it further perpetuates the myth that the public can't be responsible for understanding health and medical issues. Keeping the public less informed and more reliant on traditional (read: insanely expensive) healthcare options seems like the wrong choice. The FDA, if anything, should be encouraging more efforts to better educate the public.

Update: A petition has already been set up, by TechFreedom, asking the FDA not to ban home genomics kits and to reconsider:

We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.

We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.

The FDA is also concerned that 23andMe has not submitted anything validating that it's test is effective or accurate, which is a larger part of the issue. Not to mention the fact that the list of things they purport to test for has grown significantly since initially filing for FDA approval.

From the FDA's letter:

However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.

They're also not banning home genomics testing. They're saying that if you want to market something as a medical diagnostic test, you need to submit verifiable and credible evidence that the test is accurate. You know, ensuring that "medical" offerings aren't snake oil or fearmongering. Part of what the FDA exists for.

Re: Re:

Yes, but the concern (at least from my reading of the letter) is primarily over people reacting to inaccurate results. Like the example they give immediately after that statement:

For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect.

Re: Re: Re:

There are risks of bad effect from doctors prescriptions as well. So long as people take any concerns about results to their doctor for further advice, these sort of tests could be more of a benefit than a risk.

Re: Re: Re: Re:

Yes, there are risks from doctors as well, which is why doctors are required to go through a fairly extensive certification process. I think home genomic testing is a great idea provided the tests can demonstrate a reasonable level of accuracy. But from the FDA's letter, it seems that 23andMe has repeatedly failed to offer any credible studies to support its assertions.

Re: Re: Re: Re: Re: Re:

When certified doctors make mistakes, they get sued for malpractice.

And your belittling of the certification of doctors is bewildering, considering medical professionals are some of the most highly educated and regulated people out there. Are you saying that you have a better idea of how to increase the future supply of medical professionals?

Re: Re: Re: Re: Re: Re: Re:

1. your assertion requires several premises not in evidence: A. that every patient subject to malpractice knows they have been mistreated; this goes double for the cadavers;B. i *SUSPECT* my mother did not get A+ care during her last days; but i have no 'evidence' (other than my own witnessing her aspirating, after which i was escorted out);C. EVEN IF i did have strong suspicions *something* was wrong, WTF do i do ? ? ? start threatening doktors until one breaks ranks ? ? ?D. besides the fact that there are many grey areas where the distinction from merely average performance/bad luck, goes over the line into real malpractice...E. as well as ignoring that the medical profession is another of those privileged jobs where they 'self-police'...(meaning, NO EFFECTIVE 'policing')

2. actually, doktors are NOT some of the most 'highly regulated', you might try hairdressers, for one...(aside: did you know there is no 'legal' reason, ANY GP (repeat ANY GP) can't do brain surgery in their suburban office ? there are many *insurance*/certification reasons WHY they almost never do so (aside from the practical), but there are no 'legal' reasons they can't do ANY operation, ANY where they feel like...)

3. there is no mention that your brilliant doktors do NOT engage in even cursory DNA screening unless you shell out beaucoup bucks... AT LEAST this provides a useful screening process -no matter how inaccurate- that the doktors DO NOT...

4. really ? they are going to take a drugstore-level DNA test, and immediately upon getting a false positive they have -say- parkinson's disease, they instantaneously kill themselves ? ? ?yeah, right......or, they 'self-medicate' based on that 'diagnosis' ? ? ?sure, that seems likely...

(not saying it wouldn't happen, but by that 'logic', no one should sell razor knives, 'cause someone could operate on themselves...)

Re: Re: Re: Re: Re: Re: Re:

In any industry dominated by a cartel, quantity supplied is less than the quantity that would be supplied in a competitive market. Professional licenses are a way of enforcing cartel power.

The fact that malpractice lawsuits can be very lucrative indicates that doctors probably do make super-normal profits due to their cartel enforcing entry restrictions effectively. If they made zero economic profit as would be the case in a competitive market, they wouldn't be such a lucrative target for another cartel, the bar association.

Re: Re: Re: Re: Re: Re: Re: Re: Re:

Again, I am pointing out that licensing, certification etc act as barriers to entry, and therefore reduce competition. Just like I am recommending the removal of the FDA from the medical treatment and diagnosis market.

Removal of the FDA from the Medical Treatment and Diagnosis Market

There are EKG devices now marketed for home use. What if one such product was really just a bunch of wires that gave no useful information? Its misuse could lead someone to assume that he wasn’t having heart problems, and so not to take necessary precautions and not see as doctor.

Re: Removal of the FDA from the Medical Treatment and Diagnosis Market

Are you assuming that only the FDA is capable of figuring out that something that is being marketed as an EKG device doesn't work as advertised?

And, no, snake oil should not be regulated either.

FDA bureaucrats care only about not accidentally approving something that might be harmful. That means too many things that are useful don't get approved. The loss from the second category of error is usually not visible. The media don't try to find each and every individual because the FDA did not allow something. Dallas Buyers' Club tells the story of one group who were harmed.

This is simple statistical reasoning.

Consumers who care will be served by people who provide that information. Nothing will result in drugs that never have any adverse effects. But, I put more value on people being able to access potentially life-saving treatments than a bureaucrat does. The potential beneficiaries of something he doesn't approve are not visible to him.

Re: Re: Removal of the FDA from the Medical Treatment and Diagnosis Market

Gotcha, libertarian fantasy nut. Go back to reading your Ayn Rand fairly tale and leave the real world to the big boys and girls. Before the FDA there were more deaths. You assume that since we're receiving the benefits from the FDA that things would continue to be good without them, and that the people who advocated for this in the past were total idiots. Is it perfect? Nope. Is it some conspiracy to stop a business major from running a business? Nope. They are simply enforcing the law that a claim that you can use something as a medical diagnosis has some proof to back it up. They didn't go after the genealogy, they went after the medical side. You're wrong, you will always be wrong. Even Ayn Rand had to go on welfare.

Re: Re:

In related news, regulators are moving to ban water testing, soil pH testing, and Radio Shack multimeters on the grounds that stupid effing regulators are incapable of properly understandin g test results. Meanwhile the Department of Education is evaluating the possible effects on Common Core testing, as they are unsure which group they should consider idiots: students, teachers, parents, or themselves.

Given that the FDA mostly answers to the traditional pharmaceutical and medical industry, this seems more like a citation for criminal interference with an outdated business plan. Informed patients are not something the traditional powers in medicine want to deal with.

There is really no justification for the FDA in its current form

This leaves a paradox: The amendments seem to have harmed their intended consumer beneficiaries. Unlike other regulation which restricts output, there is no partly offsetting transfer to producers. If their effect is then essentially a deadweight loss, one is tempted to question the amendments' political viability. However, there appears to be no imminent reduction in the political demand for either the amendments or for similarly structured consumer legislation. Clearly, the sources of this political demand require examination.

10 years after he wrote that understated conclusion, the FDA actively prevented people with a very limited time to live from experimenting with therapies for themselves so that, instead, big pharma could experiment on them (see Dallas Buyers Club).

At the end of the day, it's *MY* data/information. If I want it, the government shouldn't be standing in the way, especially when the government is accumulating all the data/information it can about me.

23 and Me for genealogy

I have never been tested by 23 and Me but as a genealogist I know many people who have - for genealogical matching purposes, not for medical information. There is no question about the accuracy of the test for the areas of the genome that it covers. I also know a number of people who have taken a similar test offered by a different company (Family Tree DNA) in order to have the benefit of both. Areas not covered by one company are often covered by the other and vice versa. I understand that the overlapping areas compare very favorably. And the FDA should know that no genetic test using modern "chip" technology can be 100% accurate for closely-adjacent areas of the genome. Genealogists using DNA testing understand this.

Using my husband's 23andme results and some search engine help I purchased a pharmacogenomics textbook, sent a printout of the relevant DNA results plus copy of the relevant textbook page to my husband's dr. He took one look, said 'ok that's interesting, can I keep this?' and changed his prescription because the genomics findings immediately let him know why my husband was getting the (non-optimal) drug response that he was. The prescription change was a success, as it should have been because no-one was trying any longer to 'guess' the right drug combination. If they take 23andme off the market then they ought to ban sales of medical and science textbooks to "unqualified" people too. I love 23andme and I demand the unfettered right to information about ME, paid for by ME, without gatekeepers.

Re:

The issue is the FDA does not trust you and your doctor to make intelligent use of the information. Their attitude is you are too stupid to even have the information. But your story points out that a little more information was key to treating your husband; information that could only come from a genome analysis.

Re: Re: Re:

Great. Then make them put a label on the box stating that they don't get the FDA's gold star of approval. Locking these tests behind some sort of regulatory regime limits *my* choices. I thought the government was supposed to work for me, not against me.

Re: Re: Re: Re:

Then make them put a label on the box stating that they don't get the FDA's gold star of approval. Locking these tests behind some sort of regulatory regime limits *my* choices.

Of course it does. Just as product safety regulations limit your choice to buy dangerous toys, and environmental regulations limit your choice to buy leaded gasoline. That's what regulations do - restrict choices. As for a label, that isn't how the FDA works in any other case - they don't allow dangerous drugs to go on the market as long as they're labeled as dangerous. This is no different.

Re: Re: Re: Re: Re:

The FDA should mind its own business and so should you. If you think product x is dangerous for you then don't take it. If I want it that's my choice to make and you can keep out.

Lets not forget that the alcohol and tobacco markets are regulated to keep competition out. So they're OK so long as cartels are established and government employees and politicians can personally benefit from these cartels (in the form of campaign contributions and revolving door favors). The government is much more concerned about establishing and maintaining cartels than it is about your safety.

Re: Re: Re: Re: Re: Re:

Yest marijuana is legal despite probably being less addictive than cigarettes (which are chemically intended to be addictive) and not as bad for you as hard liquor (which is legal). If you believe the FDA has any intent at all in providing health safety you are badly deluded. The FDA makes decisions based on politics and the establishment and maintenance of cartels. I do not want the government and the FDA to manage my health. They can't manage anything else, why should I believe they should mange my health? I want them out of my life.

I don't mind having an FDA that ensures what's in the bottle is what's on the label and that the bottle contains the substances it claims to and nothing else (ie: no contaminants). But I do not want the government or you to make my health decisions for me by telling me what I can and can't do. I don't make your health decisions for you so why are you trying to impose your decisions on me. MIND YOUR OWN BUSINESS!!!

Re: Re: Re: Re: Re: Re: Re:

Maybe I'm being paranoid, but I can see the potential for this thing becoming an enabling device for hypochondriacs who'll either pester their doctor and refuse to accept they're not really ill. Or worse, start self-medicating with stuff they've bought off the internet and end up giving themselves a real health problem.

Re:

Do we really want to live in a nanny state that prevents us from being stupid? It is a slippery slope from there to 'only eat this food and think these things and only drink this amount'.

Just wait soon it will be: "No you can't have doughnut they are bad for you" ... oh crap.. that is too soon... too soon... ok, that is about trans fats and you can make a good doughnut with out them...

...but just wait some more and... watch they will try to ban bacon... and no matter how far out that is it will be too soon... waaay too soon.

Re: Re:

Re: Re:

Speaking as a citizen of a country where almost 100% of everyone's healthcare costs are covered by the taxpayer, I'm actually wholly in favour of the state preventing people from fucking up their health by acts of egregious stupidity.

Yep risks are all over that is why even in medicine you don't take the first exam result as final and do follow ups.

If 23 and me is doing something wrong or selling snake oil then sure don't give them anything but if not the FDA should explain better why it doesn't want people to test themselves or gain that capability.

"The idea that people are too stupid to understand what information 23andMe provides seems insulting to the public"

So? That would be an insult that would be absolutely true for most people. I don't know if you've noticed, but people in general are pretty damned stupid most of the time about most things. It looks to me like the FDA is trying (via hundreds of emails and video conferences) to prevent this information from being presented in ways that would do more harm than good to people too stupid to understand it. Their goal does not seem to be to shut down the company or to prevent this information from being used, but to protect people. It looks to me like they're doing their job.

"we'll reserve judgment until more details are available"

You mean like the details in hundreds of emails and 14 face-to-face and video conferences? If you really want to read all that, feel free. When you're done, perhaps you'll know enough about it to write an article on Techdirt about it.

I guess the public just have to prove by acts that they can take care of themselves and that they will not be deprived of the tools to make it happen.

If the FDA is really worried about those things and the dangers they should first and foremost "educate" people and make available the resources for others to find out about the dangers and more importantly how people can test those assertions by themselves, even if practices and methods cannot be done by individuals certainty their own communities will develop the means to test and assure locals that what is being said is true.

Get hacking people don't just assume others have your best interest at heart check it.

FDA Incompetence

The FDA is run by incompetent morons who can not explain why knowing my genome is bad for me or why one needs a prescription for medical devices such as a CPAP machine. Their only recourse it to a schoolyard bully.

Seems like a huge database of DNA out there ready to be sold to the highest bidder and people are paying for it .. if they made a diy system that would be brilliant , but to purchase a kit ship it off.. and take chances on whether or not this company is part of a bigger scheme maybe a shell insurance company ..scary thought .. but It should be able to stay on the market If others choose to use it

23andme

Mike, the FDA isn't at all saying that every claim that 23andme makes in its promotion of its service is problematic, just that there are specific claims they make in their promotional communication that can -- depending on how an individual decides how to respond -- lead to predictably negative health outcomes.

In your article you use the phrase "most people" a lot. The FDA in its review of appropriate medical claims made -- particularly in direct-to-consumer communications -- is not concerned with "most people". It is concerned with "some people" to the extent that they may use this information in a way that will predictably lead those "some people" to negative health outcomes.

Perhaps that would be an individual deciding they don't need to follow the therapy prescribed by their physician.

Perhaps, and 23andme is clear about this possibility, the test results related to a specific potential illness aren't 100% accurate -- a 'false negative'. And then an individual decides either to stop adhering to a current prescribed therapy, or not to seek benefit of any advice or intervention from a physician in the event of a possible risk factor.

This is the difference between genotype and phenotype. 23andme's test characterizes genotype. They don't claim 100% accuracy. They provide only statistical guidance as to what a specific test result may infer. Phenotype refers to a specific individual's actual medical condition based upon the specific expression of their genes, in the context of that individual's environment.

A physician's diagnosis of actual or potential illness is based upon phenotype -- the individual expression of their genotype.

There is plenty of evidence showing that incorrect patient interpretations, assumptions, or simply preferences with respect to adherence to prescribed therapy is not unusual, and can result in serious medical consequences.

Based upon the limited information I have seen, the FDA is concerned with specific claims 23andme makes in its direct-to-consumer advertising about specific medical conditions which may lead an individual to either make bad decisions to follow existing prescribed therapies, or to conclude that they can discount or eliminate the possibility that they will ever be susceptible to an illness which could be present due to their phenotype.

I can appreciate a healthy skepticism about whether the current medical delivery system and physician training environment and conditioning always lead to an optimal result. In this case, I don't think that the FDA's action is a result of either.

Re: 23andme

In your article you use the phrase "most people" a lot. The FDA in its review of appropriate medical claims made -- particularly in direct-to-consumer communications -- is not concerned with "most people". It is concerned with "some people" to the extent that they may use this information in a way that will predictably lead those "some people" to negative health outcomes.

I'd argue that protecting "some people" who can't understand fairly clear limitations of the information and how to use it while fucking over EVERYONE ELSE in terms of getting access to their own information creates many, many more "negative health outcomes."

I find it totally dishonest and ridiculous for people to screw over everyone to just protect a small group of "some people" who can't follow basic instructions.

Perhaps that would be an individual deciding they don't need to follow the therapy prescribed by their physician.

Perhaps, and 23andme is clear about this possibility, the test results related to a specific potential illness aren't 100% accurate -- a 'false negative'. And then an individual decides either to stop adhering to a current prescribed therapy, or not to seek benefit of any advice or intervention from a physician in the event of a possible risk factor.

Or, perhaps people find out accurate information and are able to help better their lives. Yet the FDA precludes ALL of that.

Nothing is going to be 100% accurate. People aren't so stupid. Most understand this.

There is plenty of evidence showing that incorrect patient interpretations, assumptions, or simply preferences with respect to adherence to prescribed therapy is not unusual, and can result in serious medical consequences.

Re: Re: 23andme

I find it totally dishonest and ridiculous for people to screw over everyone to just protect a small group of "some people" who can't follow basic instructions.

You're saying this company should be permitted to continue performing these tests without offering any evidence that they're accurate. They could be using a random number generator for all we know. It really doesn't matter how well people can follow instructions, or how small this group is that you keep insisting is insignificantly small without any evidence.

Nothing is going to be 100% accurate.

Is that what the FDA is demanding? No? Then why are you bringing it up?

Being totally ignorant is worse.

Then why are you blaming the FDA, rather than 23AndMe for failing, over a long period of time, and with multiple communications and opportunities to comply, to do what they knew perfectly well needed to be done to keep their product on the market?

Re: 23andme

There is plenty of evidence showing that incorrect patient interpretations, assumptions, or simply preferences with respect to adherence to prescribed therapy is not unusual, and can result in serious medical consequences.

There is also plenty of evidence showing that incorrect doctor interpretations, assumptions, or simply preferences with respect to adherence to prescribed therapy is not unusual, and can result in serious medical consequences. It's quite common.

So when are they going to say that doctors shouldn't be allowed access to your medical information?

I assume 23andme has no lobbyists to deal with drug companies who lobby against themPerhaps they should do some 6-8 week trials then submit 2 that prove their testing was correct to get their product approved. You can do thousands of trials and as long as two show positive effect your drug gets approved (the cards are stacked in favour of the drug, but since this is not a drug i assume the FDA will make them be more stringent because information is more deadly then poisonous drugs)

Burdens of proof

Under the several of the statutes that the FDA is charged with enforcing, companies that sell drugs, or medical devices, have the burden of showing effectiveness for the advertised purpose (gross simplification of the standard; there are a variety of requirements depending on the risks associated with the device). Here, the interpretive question is whether a home testing kit is a medical device. Mike, do you disagree with the FDA's conclusion that it is?

Once you get past that, then the question is whether the company has made a sufficient showing of effectiveness. The FDA says that showing has not yet been made here. This strikes me as an example of the FDA earnestly doing its job.

Re: Burdens of proof

And, the FDA earnestly doing its job destroys the wealth of the nation as Peltzman showed and as many AIDS patients painfully discovered during the 80s.

And, the the FDA earnestly doing its job enables big pharma to engage in international price discrimination. They should be free to try, but it is inappropriate, to say the least, that the government lends them a hand.

the fda truly seems to simply, nearly exclusively, perpetuate the ability of some people to make money--including themselves. its not necessarily a non-noble cause--but it also is; perpetuating peoples suffering so that other people can have jobs.tests like this potentially allow peopel to access information that will resolve years of a mystery illness, or psychiatric condition (especially the latter, since psychiatrists literally 'guess and check' and generally not even that well/without much reasoning) for less than the price of a single appointment. also,its not as if there is any cause to believe that this lab is any less competent than the labs your dr would order a genetic test from; they simpy offer your entire genome at a significantly lower price (probably less than your dr charges simply for scheduling an appointment). of course, as of a few months or so ago, the fda is also attempting to gain regulation of other labs. i mean, how about if people complain, they investigate--not simply try to control evertyhing under false pretenses that they care abut peoples safety (I find it difficult to believe anyone thinks that they do) and with our tax money.

ps -this is a single wrongdoing. never used to be remotely a conspiricist ut the medical industry drives me crazy. the fact that the fda charges billions of dollars to conduct trials an approvee drugs (how can anythig they do actually cost/be worth anywhere near that much?) also has massive repurcussions. for example there is a certain one Tianeptine that is supposedly majorly effective for depression but despite being prescribed in many other countries will probabty never be available here because of the cost for a company to produce it(not literally produce, but gain fda approval to produce it) , and expired exclusivety to patent =many people with a crippling disorder are denied a potential cure.